NCT06198660

Brief Summary

The goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain. The main question aims to answer :Is there any differences of using positional release techniques versus cognitive behavioral therapy on patients with chronic low back pain?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

December 18, 2023

Last Update Submit

January 10, 2024

Conditions

Chronic Non Specific Mechanical Low Back Pain

Keywords

positional releasecognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • pressure algometer

    change in pain pressure threshold .with unit of measurement kg/cm2

    pre intervention and immediately after intervention

Secondary Outcomes (1)

  • the arabic version of oswestry disability questionnaire

    pre intervention and immediately after intervention

Study Arms (3)

positional release

EXPERIMENTAL

positional release techniques in addition to conventional physical therapy

Other: positional release technique

cognitive behavioral therapy

EXPERIMENTAL

cognitive behavioral therapy in addition to conventional physical therapy

Other: cognitive behavioral therapy

conventional physical therapy

ACTIVE COMPARATOR

conventional physical therapy in control group

Other: positional release techniqueOther: cognitive behavioral therapyOther: conventional therapy only

Interventions

positional release techniqueOTHER

positional release techniques in addition to conventional therapy two sessions per week for 6 weeks

conventional physical therapypositional release
cognitive behavioral therapyOTHER

cognitive behavioral therapy in addition to conventional therapy two sessions per week for 6 weeks

cognitive behavioral therapyconventional physical therapy
conventional therapy onlyOTHER

conventional therapy two sessions for 6 weeks

conventional physical therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients will be clinically diagnosed with chronic non specific low back pain .
  • Their ages will range from 20to40years old.
  • body mass index will range from 18 to 30 kg/cm².
  • Cognitive score will be 23 or above .
  • Voluntary acceptance of participation in this study.

You may not qualify if:

  • Lumbar canal stenosis
  • Lumbar discogenic lesions
  • Lumbar infections,tumors.arthiritis
  • Patients with decreased range of motion due to congenital anamolies.
  • Cognitive and emotional disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horus University

Damietta, New Damietta, Egypt

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nosaiba Eissa

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nosaiba Eissa

CONTACT

01005305615neissa@horus.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 10, 2024

Study Start

September 15, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

EG(1)